MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PASSPORT; DILATOR, CATHETER, URETERAL

Model Number	M0062181100
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a passport balloon dilatation catheter was used in the ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, while attempting to inflate the balloon to 7 atm, the balloon burst.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block h6: device code 1074 captures the reportable issue of balloon burst.Block h10: investigation results: a visual examination of the returned complaint device found that the balloon was not folded which indicates that the balloon was subjected to positive pressure and was noted to have a balloon longitudinal tear.The shaft was noted to be kinked and the tip was damaged.This problem could occur due to factors encountered during the procedure, such as the unreported kink noted during device analysis occurred most likely as a result of interaction between the user and the device, at which stage of the procedure it occurred cannot be established.The tip shows signs of damage consistent with the device meeting a resistance or obstruction inside the patient during procedure.The device may have encountered difficult patient anatomy such as a high percentage of stenosis, calcification or tortuosity and it is possible that this would have contributed to a rupture in the balloon material.The most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a passport balloon dilatation catheter was used in the ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, while attempting to inflate the balloon to 7 atm, the balloon burst.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: PASSPORT
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11002319
• Report Number: 3005099803-2020-06048
• Device Sequence Number: 16301136
• Product Code: EZN
• UDI-Device Identifier: 08714729191872
• UDI-Public: 08714729191872
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K941853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2022
• Device Model Number: M0062181100
• Device Catalogue Number: 218-110
• Device Lot Number: 0024827973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1